NCT02634203

Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

"Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary hypertension characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right failure. In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment and is the only potentially curative treatment. However, some patients are ineligible for surgery owing to occlusion of distal vessels. The best treatment option for these non-operable CTEPH patients is not yet established.

Detailed description

Currently, riociguat is the only drug approved in Europe and US for the treatment of non-operable CTEPH. However, medical therapy with riociguat does not address obstructive lesions. In this sense, another treatment option, balloon pulmonary angioplasty (BPA), began recently to gain widespread interest after development in several centers. This procedure uses the standard balloon angioplasty technique to dilate selected pulmonary arteries. The main aim is to reopen vessels occluded by webs and bands. Several teams, mainly from Japan, have reported their experiences with BPA for the treatment of non-operable CTEPH and demonstrated impressive decrease in pulmonary vascular resistance and improvement in functional status and exercise capacity with an acceptable procedure-related risk. Although BPA has never been prospectively evaluated, most of the leading CTEPH centers worldwide have currently added BPA to their therapeutic options. However, no randomized controlled trial comparing safety and efficacy of medical therapy with riociguat versus pulmonary balloon angioplasty has been performed so far. Therefore, the respective places of medical treatment and of BPA in the management of inoperable patients with CTEPH need to be further evaluated. An ancillary study will evaluate the efficacy and safety of employment of two sequentially used treatments at 12 months. The studied population is that of the study RACE. The patient follow-up period will be extended by 6 months, its duration of participation will be in total of 13 months. The exams will be the same as those of the V3 of the RACE study.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Balloon Pulmonary Angioplasty (BPA)	Balloon pulmonary angioplasty (BPA) will be done via femoral vein. 2 sessions will be performed during the same hospitalization following by additional sessions at an interval of 2-3 weeks until a mean PAP\< 30 mmHg is achieved A pulmonary angiography and a right heart catheterization will be performed at each BPA session
DRUG	Riociguat	The starting dose will be 1 mg three times daily as recommended. The dose will be titrated every 2 weeks according to the peripheral systolic pressure. Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension.

Timeline

• Start date: 2016-01-19
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2015-12-17
• Last updated: 2021-01-26

Locations

1 site across 1 country: France